Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences
SafetyAlerts
August 20, 2003

Novartis Pharmaceuticals Has Recalled Combipatch Transdermal System

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Combipatch Transdermal System, (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day, 3 Patient Calendar Packs of 8 Systems, Rx only. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey Recall # D-304-3.

CODE
Lot Number: 61921011, Expiry 06-2004.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Pharmaceuticals, Corp, Suffern, NY, by letter on July 3, 2003.
Manufactured by: Noven Pharmaceuticals, Inc., Miami, Florida. Firm initiated recall is ongoing.

REASON
Subpotency (estradiol/NETA) and Degradation failure (excess primary estradiol degradant).

VOLUME OF PRODUCT IN COMMERCE
256,608 patches.

DISTRIBUTION
Nationwide.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.